Duns Number:079290879
Device Description: The CVC WAND Safety Introducer with Valved Peelable Sheath
Catalog Number
93001
Brand Name
CVC WAND
Version/Model Number
7Fr X 6cm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
4bcfd01e-5c22-4f35-9c1f-cda79212d795
Public Version Date
December 09, 2019
Public Version Number
3
DI Record Publish Date
October 11, 2018
Package DI Number
20859821006708
Quantity per Package
12
Contains DI Package
10859821006701
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |